FDA 510(k)

VariFuse Adjustable Infusion Catheter

N.º K: K251318 · 2026-01-20

Fecha de decisión2026-01-20

Código de productoQEY

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

VariFuse Adjustable Infusion Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Argon Medical Devices, Inc.. It received FDA 510(k) clearance on 2026-01-20 under 510(k) number K251318. The device is classified under product code QEY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the VariFuse Adjustable Infusion Catheter?

VariFuse Adjustable Infusion Catheter is a medical device that received FDA 510(k) clearance on 2026-01-20. The listed applicant is Argon Medical Devices, Inc.. The 510(k) number is K251318.

When did VariFuse Adjustable Infusion Catheter receive FDA 510(k) clearance?

VariFuse Adjustable Infusion Catheter received FDA 510(k) clearance on 2026-01-20, under 510(k) number K251318.

Who is the listed applicant for VariFuse Adjustable Infusion Catheter?

The FDA 510(k) record lists Argon Medical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VariFuse Adjustable Infusion Catheter?

The FDA product code for VariFuse Adjustable Infusion Catheter is QEY.

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Otros registros que enlistan a Argon Medical Devices, Inc. como solicitante

K252795ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial K260028CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration Canister K253741V•Stick™ Vascular Access Set K242612Option ELITE Vena Cava Filter System (352506070E 352506100E)K241145TLAB® Transvenous Liver Biopsy System (TF-18C)K233909Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™ Plus 18F Handpiece with Maceration Wire, Cleaner™ Plus 18F Aspiration Canister

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Dispositivos relacionados (Código: QEY)

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Fuente oficial

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